Orthopedic Instruments Manufacturers in Australia

ARTG inclusion is for a "kind of device" under a specific sponsor. If that sponsor is your distributor and you move to another distributor, the ARTG entry does not automatically follow; changing sponsor requires a TGA process, and the new sponsor takes on the obligations.

Before appointing a distributor-sponsor, agree in writing who controls the ARTG entries and the technical evidence, and how a handover would work. Some overseas manufacturers use an independent sponsor service so they can change distributors more easily. Australian listings, including the Bayswater city page, are on the Australia country page.

Australia

The Australian Register of Therapeutic Goods (ARTG) is the TGA's register of therapeutic goods that can be lawfully supplied in Australia. Unless exempt, a medical device must be included in the ARTG before it is imported, supplied or exported.

Only an Australian sponsor (an Australia-based legal entity) can apply; overseas manufacturers cannot apply directly. The sponsor holds or can obtain the manufacturer's evidence, such as a TGA certificate, accepted overseas evidence (for example EU notified body certificates, FDA decisions or MDSAP certificates), or a manufacturer's declaration for Class I non-sterile, non-measuring devices. ARTG inclusion is for a "kind of device" under that sponsor, so changing sponsor needs a TGA process. See the medical certifications page.

Medical certifications

Only an Australian sponsor can apply to include a device in the ARTG; overseas manufacturers cannot apply directly. The sponsor must be an Australia-based legal entity. It must hold, or have a written agreement to obtain, the manufacturer's evidence of Essential Principles compliance and conformity assessment. It also reports adverse events, takes part in recalls, keeps distribution records and follows advertising rules for as long as the ARTG entry has effect.

Foreign exporters usually supply through an Australian distributor acting as sponsor, or a specialist sponsor service. Australian companies, currently more than 10, are listed on the Australia country page.

Australia